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2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

W

Watson Pharmaceuticals

Status and phase

Completed
Phase 3
Phase 2

Conditions

Iron Deficiency Anemia

Treatments

Drug: Oral Iron
Drug: Sodium Ferric Gluconate Complex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00223977
FR03001

Details and patient eligibility

About

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Enrollment

146 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female, at least 18 years of age.
  • Received maintenance peritoneal dialysis therapy for at least 4 weeks.
  • Was expected to remain on peritoneal dialysis therapy for duration of study.
  • Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
  • Signed patient informed consent.

Exclusion criteria

  • Had a predetermined serum levels of Ferritin and TSAT
  • Pregnant or lactating.
  • Had a serious concomitant medical disorder incompatible with participation in the study.
  • Had a known hypersensitivity to Ferrlecit or any of its components.
  • Unable to cooperate or comply with the protocol.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

146 participants in 3 patient groups

Sodium ferric gluconate complex 125 mg
Experimental group
Description:
125 mg sodium ferric gluconate weekly x 8 weeks
Treatment:
Drug: Sodium Ferric Gluconate Complex
Drug: Sodium Ferric Gluconate Complex
Sodium ferric gluconate complex 250 mg
Experimental group
Description:
250 mg sodium ferric gluconate complex weekly x 4 weeks
Treatment:
Drug: Sodium Ferric Gluconate Complex
Drug: Sodium Ferric Gluconate Complex
Oral iron
Active Comparator group
Description:
325 mg ferrous sulfate three times daily x 8 weeks
Treatment:
Drug: Oral Iron

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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